[The accreditation of a surgical pathology and somatic genetic laboratory (LPCE, CHU of Nice) according to the ISO 15189 norm: Sharing of experience]

Abstract

Accreditation is going to be vital and unavoidable in the medium term for medical biology laboratories in France. This accreditation will certainly condition the authorization to conduct biological testing in the health care system. All the biological specialities are now affected by this procedure, including the somatic genetics. The anatomo-pathology, which is a medical speciality in France, may be also concerned by the accreditation. However, the nature and the practices of this specialty increase the complexity of this approach to be implemented according to the standard requested by the authorities, i.e. the ISO 15189 normative standard (standard on "specific requirements for quality and competence for medical biology analysis laboratories"). The present article recounts the experience of a hospital laboratory (LPCE, Nice University Hospital) composed of a surgical pathology and a somatic genetics unit: (1) in the accreditation process according to the ISO 15189 standard, (2) at the time of the audit made by the team of "COFRAC" evaluators, and, (3) in evaluating the strategy implemented following the audit.

Keywords: Accreditation; Accréditation; Anatomo-pathologie; COFRAC; Génétique somatique; ISO 15189 norm; Norme NF EN ISO 15189; Pathology; Somatic genetics.